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RSS FeedPosted by Michael Wonder on 27 Jan 2021
Australia’s COVID-19 vaccine information campaign begins
27 January 2021 - The Australian Government’s $23.9 million public information campaign to encourage Australians to get a COVID-19 vaccine begins ...
Posted by Michael Wonder on 27 Jan 2021
European Commission approves Keytruda (pembrolizumab) as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
26 January 2021 - Keytruda is first checkpoint inhibitor approved in Europe to treat MSI-H or dMMR colorectal cancer. ...
Posted by Michael Wonder on 27 Jan 2021
Alleviant Medical receives breakthrough device designation from FDA for transcatheter technology
25 January 2021 - Alleviant Medical today announced that the US FDA has granted the company a breakthrough device designation ...
Posted by Michael Wonder on 27 Jan 2021
PEDRA Technology receives FDA breakthrough device designation for its PEDRA Xauron real-time tissue perfusion system
25 January 2021 - Novel perfusion monitor achieves FDA breakthrough device Designation for real-time, peri-procedural monitoring of tissue perfusion in patients ...
Posted by Michael Wonder on 26 Jan 2021
Scott Morrison says Australia will not be a hostage to global vaccine shortages
26 January 2021 - Scott Morrison has revealed why Australia won’t be “completely hostage” to overseas vaccine schedules and shortages. ...
Posted by Michael Wonder on 26 Jan 2021
MeiraGTx announces AAV-CNGA3 granted fast track designation by U.S. FDA for treatment of achromatopsia
26 January 2021 - MeiraGTx today announced that the U.S. FDA has granted fast track designation to its AAV-CNGA3 gene therapy ...
Posted by Michael Wonder on 26 Jan 2021
Recordati Rare Diseases: Carbaglu (carglumic acid) receives U.S. FDA approval for a new indication to treat acute hyperammonaemia associated with propionic acidemia and methylmalonic acidemia
26 January 2021 - Carbaglu is first and only FDA approved medication for hyperammonaemia associated with these rare conditions. ...
Posted by Michael Wonder on 26 Jan 2021
Vertex announces U.S. FDA acceptance of supplemental new drug application for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations
26 January 2021 - FDA grants priority review of the application and sets a PDUFA target action date of 8 June ...
Posted by Michael Wonder on 26 Jan 2021
FDA approves Theranica's Nerivio for acute treatment of migraine in adolescents
25 January 2021 - Theranica today announced that its Nerivio therapeutic device has received the FDA clearance to market for ...
Posted by Michael Wonder on 26 Jan 2021
Albireo announces U.S. FDA acceptance of new drug application for odevixibat
25 January 2021 - FDA has granted odevixibat fast track, rare paediatric disease and orphan drug designations. ...
Posted by Michael Wonder on 26 Jan 2021
Iterum Therapeutics announces U.S. FDA filing acceptance of new drug application for oral sulopenem
25 January 2021 - If approved, first oral penem in the U.S. and first new oral treatment for uUTIs in over ...
Posted by Michael Wonder on 25 Jan 2021
AstraZeneca is finding it hard to keep its COVID-19 vaccine promises
26 January 2021 - As countries scramble to inoculate their populations against COVID-19, the vaccine developed by AstraZeneca and the ...
Posted by Michael Wonder on 25 Jan 2021
European Commission approves AbbVie's Rinvoq (upadacitinib) for the treatment of psoriatic arthritis and ankylosing spondylitis
25 January 2021 - Approval is supported by data from three pivotal clinical studies in psoriatic arthritis and ankylosing spondylitis where ...
Posted by Michael Wonder on 25 Jan 2021
EMA publishes agenda for 25-29 January CHMP meeting
25 January 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 Jan 2021
Coronavirus: Pfizer jab cleared for first rollout, with more planned
25 January 2021 - Pharmaceutical giant Pfizer says it is open to providing more doses of its vaccine to Australia ...